Back to resultsSafety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Disease, Anaemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Monofer
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease
Eligibility Criteria
Inclusion Criteria:
- Completed the Lead-in Study or discontinued from Lead-in Study due to intolerance to oral iron.
- Life expectancy beyond 18 months by Investigator's judgement.
- Willingness to participate after informed consent. -
Exclusion Criteria:
- Discontinuation from Lead-in Study (except for due to intolerance to oral therapy).
- Any major protocol deviation in Lead-in Study.
- Pregnancy and nursing [To avoid pregnancy, women have to be postmenopausal, surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, Intrauterine Devices (IUD), contraceptive injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches].
- Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study.
Patients with a Harvey-Bradshaw Index >8 or Partial Mayo Score (excluding Endoscopy Sub-score) >6 at End of Study Visit of Lead-in Study.
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Sites / Locations
- Austria
- Hungary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Long term efficacy
To assess the long term efficacy of iron isomaltoside 1000 (Monofer®) by means of the ability to maintain stable Hb (defined as Hb ≥ 12.0 g/dL) in subjects with Hb ≥ 12.0 g/dL at the Baseline of Extension Study.
To assess the ability to achieve stable Hb (Hb ≥ 12.0 g/dL) at Month 3 Visit of Extension Study, and then to maintain the stable Hb thereafter in subjects with Hb < 12.0 g/dL at Baseline of Extension Study.
Secondary Outcome Measures
Long term safety
To assess the long term safety of iron isomaltoside 1000 (Monofer®) maintenance, measured through laboratory testings and number of subjects who experience any adverse drug reaction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01410435
Brief Title
Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease
Official Title
An Open-label, Multi-Centre, Non-Randomised Extension Study to Assess the Ability to Maintain a Stable Haemoglobin and to Assess Safety of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacosmos A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Since the duration of most studies with IV iron in IBD subjects have been only 4-12 weeks studies there is a need to follow-up on long term safety and efficacy of any maintenance iron therapy.
This study represents subjects from the Lead-in Study (P-Monofer-IBD-01) on iron isomaltoside 1000 (Monofer®) to assess the long term safety of iron isomaltoside 1000 (Monofer®) and its ability to maintain stable haemoglobin in IBD subjects with Iron Deficiency Anaemia (IDA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Anaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Monofer
Intervention Description
Infusion according to current HB level
Primary Outcome Measure Information:
Title
Long term efficacy
Description
To assess the long term efficacy of iron isomaltoside 1000 (Monofer®) by means of the ability to maintain stable Hb (defined as Hb ≥ 12.0 g/dL) in subjects with Hb ≥ 12.0 g/dL at the Baseline of Extension Study.
To assess the ability to achieve stable Hb (Hb ≥ 12.0 g/dL) at Month 3 Visit of Extension Study, and then to maintain the stable Hb thereafter in subjects with Hb < 12.0 g/dL at Baseline of Extension Study.
Time Frame
Baseline to month 12
Secondary Outcome Measure Information:
Title
Long term safety
Description
To assess the long term safety of iron isomaltoside 1000 (Monofer®) maintenance, measured through laboratory testings and number of subjects who experience any adverse drug reaction.
Time Frame
Baseline to month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completed the Lead-in Study or discontinued from Lead-in Study due to intolerance to oral iron.
Life expectancy beyond 18 months by Investigator's judgement.
Willingness to participate after informed consent. -
Exclusion Criteria:
Discontinuation from Lead-in Study (except for due to intolerance to oral therapy).
Any major protocol deviation in Lead-in Study.
Pregnancy and nursing [To avoid pregnancy, women have to be postmenopausal, surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, Intrauterine Devices (IUD), contraceptive injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches].
Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study.
Patients with a Harvey-Bradshaw Index >8 or Partial Mayo Score (excluding Endoscopy Sub-score) >6 at End of Study Visit of Lead-in Study.
-
Facility Information:
Facility Name
Austria
City
Austria
Country
Austria
Facility Name
Hungary
City
Hungary
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease
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